saba; ACE; Appetite Control Energy; 052234; 07/2015; Distributed by Saba; 711 NE 39th…

AMS Health Sciences recalled this product and the FDA reported the enforcement action on 15 October 2014 as Class II. The recall was initiated by the firm. Product called SABA ACE (Appetite Control Energy) that was manufactured prior to September 2013 was found to have DMAA (1,3-Dimethylpentylamine) based on label and laboratory analysis. the DMAA was removed when the product was reformulated in September 2013.

The record

Every field below is published by the FDA in the openFDA food enforcement database. Check the FDA notice before acting on any recall: this page is a reading of the public record, not a substitute for it.

Product

saba; ACE; Appetite Control Energy; 052234; 07/2015; Distributed by Saba; 711 NE 39th Street, Oklahoma City, OK 73105

Reason for recall

Product called SABA ACE (Appetite Control Energy) that was manufactured prior to September 2013 was found to have DMAA (1,3-Dimethylpentylamine) based on label and laboratory analysis. the DMAA was removed when the product was reformulated in September 2013.

Recalling firm

AMS Health Sciences

Firm location

Oklahoma City, Oklahoma, United States

Classification

Class II

Status

Terminated

Recall number

F-0018-2015

Quantity

1,021,350 - 2 pack samples; 8,595,450 - 60 ct bottle

Distribution

OK, CO,

Initiated

26 February 2014

Reported by FDA

15 October 2014

Terminated

22 September 2016

Firm notified by

Other

Product codes

Lot Numbers: 81721, 81722, 101022, 61327, 61328, 61329, 31424, 31422, 31423, 40926, 40925, 33125, 31421, 31324, 30922, 30923, 30924, 31322, 31323, 31321, 12428, 30925, 12426, 21325, 12521,112214, 112216, 52231, 52232, 20634, 31832, 31833, 40833, 31831, 31838, 33033, 330353, 33031, 33034, 33032, 31834, 31837, 31835, 31836, 20634, 20635, 21837, 21834, 21835, 21836, 31537, 11131, 20633, 121024, 121025, 121026, 121027, 21831, 36000250, 110524, 110525, 101024, 33126, 61325, 981723, 101023, 110523

Reading this record

Five things about this record are not in the record itself, and each one changes how it should be read.

• Class II means the FDA judged a remote probability of serious harm, or a probability of temporary or medically reversible harm. The class is assigned by an agency health hazard evaluation under 21 CFR 7.41, not by the firm.
• The firm started this recall itself. Most FDA food recalls are voluntary, and a recall is a food safety plan working rather than failing. The circumstances in which the agency asks for one instead are set out in 21 CFR 7.45.
• This record is the only one the FDA opened for its recall event, so it covers a single product code.
• The recall ran for 2.6 years, from 26 February 2014 to termination on 22 September 2016. Termination means the agency judged that all reasonable effort had been made, under 21 CFR 7.55, and it says nothing about whether product remained in circulation.
• The distribution pattern names 2 states, and the FDA published the enforcement report 8 months after the firm began the recall.
• The product description on this record names no food this site can classify, so it appears on no food-type page. That is a limit of the description rather than of the recall.

Named in the distribution pattern: Oklahoma, Colorado. Those pages count recalls by where the RECALLING FIRM sits, which is a different question from where this product went.

Other records from AMS Health Sciences

The FDA opens one enforcement record per product code, so several of these are frequently one recall event.

All 2014 recalls · All FDA food recall data